The Comparison of Efficacy and Safety between Intramuscular and Topical Testosterone for Pediatric Hypospadias

Abstract

Introduction: Preoperative testosterone administration in children with hypospadias can help the penis reach an optimal size, facilitating surgery. However, some literature reports varying effectiveness between intramuscular and topical testosterone administration. This study aims to evaluate the differences in penis enlargement and complications in children with hypospadias between intramuscular and topical testosterone administration. Methodology: A randomized clinical trial (RCT) was performed to evaluate the effects of testosterone administration routes on penile dimension & complications in children with hypospadias. This study was conducted at Dr. Hasan Sadikin General Hospital in Bandung from March 2023 to March 2024. Thirty participants were divided into groups of intramuscular (2 mg/kg every 3 weeks, given in 3 doses; n=15) and topical (2.5% topical gel 2 times daily for 4 weeks; n=15) equally using a lottery method (simple random sampling).  Results and Discussion: The mean age was 6+3 in both groups, with posterior hypospadias being the most common type. Intramuscular testosterone yielded significant improvements in stretched penile length (SPL) (MD 5.7 (1.2 – 10.2), p = 0.015) and glans width (MD 1.7 (0.1 – 3.4), p = 0.043) compared with topical application; no significant difference was observed on urethral plate width (MD 0.4 (-0.9–1.7), p = 0.523). One patient in the injection group reported pubic hair growth after the intervention. Conclusion: Intramuscular testosterone was significantly better for increasing the SPL and penile glans size compared with topical testosterone in pediatric hypospadias. No significant difference in complications was observed between both groups.